Product Lifecycle Services
RCA’s expertise in pharmaceuticals extends to existing products on the market. We can help with regulatory strategy and dossier content management throughout your product’s entire lifecycle, including the following:
- Annual Reports and Periodic Adverse Drug Experience Reports (PADERs)
- Changes Being Effective: CBE-0 and CBE-30 Supplements
- Prior Approval Supplements (PAS)
- Abbreviated New Drug Application (ANDA)
- Amendments
- Changes to Supplier Sourced Material
- Changes to Meet New Agency Publishing Requirements
- Type I and Type II Variations (EU)
Our broad range of Medical Device Regulatory Affairs consulting services include:
